BEUDAMED
    FDA Adverse Event Death Summary report: N

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    MDR report key: 2464874 · Received February 22, 2012

    Report

    Report Number
    2531779-2012-01413
    Event Type
    Death
    Date Received
    February 22, 2012
    Report Date
    March 22, 2011
    Manufacturer
    ANIMAS CORPORATION
    Product Code
    LZG
    PMA / PMN Number
    K080639
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP HAS NOT BEEN RETURNED TO ANIMAS FOR EVALUATION. IF THE DEVICE IS RETURNED, AN EVALUATION SHALL BE COMPLETED AND A SUPPLEMENTAL REPORT WILL BE FILED. NO CONCLUSIONS CAN BE MADE AT THIS TIME.

    Additional Manufacturer Narrative · 1

    FOLLOW UP #1 SUBMITTED: 12-FEB-2018. THE DEVICE WAS RETURNED TO THE MANUFACTURER AND INVESTIGATED BY PRODUCT ANALYSIS ON 29-JAN-2018 WITH THE FOLLOWING FINDINGS: ON INVESTIGATION, THE PUMP WAS INTACT AND WITHOUT DAMAGE. ON TESTING, THE PUMP POWERED ON NORMALLY AND WAS EXERCISED FOR 24 HOURS WITHOUT ANY INDICATION OF PRODUCT MALFUNCTION. THERE WAS NO DAMAGE, DEFECT OR CONTAMINATION OF THE PUMP'S INTERIOR COMPONENTS. THE DISPLAY WAS NOTED TO BE DIM/DISCOLORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED IN (B)(6) 2010 DUE TO CARDIO-RESPIRATORY FAILURE FOLLOWING EMERGENCY SURGERY FOR A RARE GENETIC DISORDER. THE PATIENT'S PHYSICIAN REPORTED THAT THE PUMP IS NOT IMPLICATED IN THE PATIENT'S DEATH; THE PATIENT WAS NOT USING THE PUMP FOR INSULIN AND WAS USING IT TO DELIVER IGF1 AND AN EXPERIMENTAL DRUG FOR THE GENETIC DISORDER. THERE IS NO ALLEGATION OR EVIDENCE THAT THE PUMP CAUSED OR CONTRIBUTED TO THE PATIENT'S DEMISE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ONETOUCHPING GLUCOSEMGMTSYSTEM INSULIN INFUSION PUMP LZG ANIMAS CORPORATION ONETOUCH PING INSULIN PUMP

    Patients

    Seq Age Sex Outcome Treatment
    1 Death